VENTANA PD-L1 (SP263) Assay

FDA Premarket Approval P160046 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for minor software changes.

DeviceVENTANA PD-L1 (SP263) Assay
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantVentana Medical Systems, Inc.
Date Received2020-01-13
Decision Date2020-03-31
PMAP160046
SupplementS007
Product CodePLS 
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Ventana Medical Systems, Inc. 1910 E. Innovation Park Dr. tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P160046Original Filing
S015 2022-10-14 30-day Notice
S014 2022-07-12 30-day Notice
S013
S012 2022-02-16 Special (immediate Track)
S011 2022-01-28 135 Review Track For 30-day Notice
S010 2021-06-14 Panel Track
S009 2021-02-22 Real-time Process
S008 2020-08-26 Real-time Process
S007 2020-01-13 Real-time Process
S006 2019-08-22 Real-time Process
S005 2018-06-18 Real-time Process
S004 2018-04-03 Normal 180 Day Track No User Fee
S003
S002
S001 2017-07-17 30-day Notice

NIH GUDID Devices

Device IDPMASupp
04015630972784 P160046 000
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